NCT00768196

Brief Summary

The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

First QC Date

October 1, 2008

Last Update Submit

December 6, 2010

Conditions

Keywords

GERDKoreatypical symptomquality of lifeNaturalisticepidemiological

Outcome Measures

Primary Outcomes (1)

  • The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.

Secondary Outcomes (1)

  • The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

general hospital sample

You may qualify if:

  • GERD patients who have experienced heartburn or acid regurgitation during past 7 days
  • GERD patients who have already undergone endoscopy before enrolment

You may not qualify if:

  • Involvement in the planning and conduct of the programme
  • The person who took the medicine such as PPI or H2RA during the last 7 days
  • Severe systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Cheonan, Chungcheongnam-do, South Korea

Location

Research Site

Seoul, Kyungkido, South Korea

Location

Research Site

Sungnam, Kyungkido, South Korea

Location

Research Site

Suwon, Kyungkido, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Joon-Woo Bahn

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 7, 2008

Study Start

September 1, 2008

Study Completion

February 1, 2009

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations